Autoimmune EncephalitisVal-Dia scoreNCT05953974
Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin
An observational study of Autoimmune Encephalitis and Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The investigators wish to test a diagnostic risk score for autoimmune encephalitis in case of encephalitis, previously validated by two American teams, in a retrospective analysis, according to the clinical and paraclinical data available in our database of the Reference Centre for Autoimmune Encephalitis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis, Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder)
- What is being tested?
- Clinical score of Granillo and al.
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : * Anti NMDAr * Anti LGI1 * Anti CASPR2 * Anti GABAb * Anti GAD
Who may be able to join
- Age > 18 years old
- Patient with a definite auto-immune encephalitis (Graus and al. 2016)
Who cannot join
- Uncomplete data in acute phase
- Patient with several antibodies
- Opposition
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
Lyon
About this study
The investigators wish to test a diagnostic risk score for autoimmune encephalitis in case of encephalitis, previously validated by two American teams, in a retrospective analysis, according to the clinical and paraclinical data available in our database of the Reference Centre for Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes of Professor Honnorat for patients with NMDAr, anti LGi1, anti CASPR2, anti GABAbr and anti GAD antibodies.
- Conditions
- Autoimmune Encephalitis, Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder)
- Being tested
- Clinical score of Granillo and al.
- Keywords
- Diagnostic score, auto-immune encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical score of Granillo and al.Other
Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.
| Study group | Role | What they receive |
|---|---|---|
| NMDAr patients | Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :
- Anti NMDAr Receives: Other: Clinical score of Granillo and al. | |
| LGI1 patients | Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :
- Anti LGI1 Receives: Other: Clinical score of Granillo and al. | |
| CASPR2 patients | Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :
- Anti CASPR2 Receives: Other: Clinical score of Granillo and al. | |
| GABAb patients | Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :
- Anti GABAb Receives: Other: Clinical score of Granillo and al. | |
| GAD patients | Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :
- Anti GAD Receives: Other: Clinical score of Granillo and al. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a diagnostic score for encephalitis to assess the risk of autoimmune origin.
Comorbidities assessed by the Charlson score
Measured: At baseline
Symptoms in the acute phase
Measured: At baseline
Mode of onset of disease
Measured: At baseline
Results of lumbar puncture
Measured: At baseline
Results of antineuronal antibodies in CSF
Measured: At baseline
Results of antineuronal antibodies in serum
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953974
- Sponsor's protocol ID
- 69HCL23_0627
- Acronym
- Val-Dia score
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin
- ClinicalTrials.gov ID
- NCT05953974
- Acronym / sponsor ID
- Val-Dia score / 69HCL23_0627
- Conditions
- Autoimmune Encephalitis, Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder)
- Keywords
- Diagnostic score, auto-immune encephalitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wish to test a diagnostic risk score for autoimmune encephalitis in case of encephalitis, previously validated by two American teams, in a retrospective analysis, according to the clinical and paraclinical data available in our database of the Reference Centre for Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes of Professor Honnorat for patients with NMDAr, anti LGi1, anti CASPR2, anti GABAbr and anti GAD antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NMDAr patients | – | Other: Clinical score of Granillo and al.Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : - Anti NMDAr |
| LGI1 patients | – | Other: Clinical score of Granillo and al.Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : - Anti LGI1 |
| CASPR2 patients | – | Other: Clinical score of Granillo and al.Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : - Anti CASPR2 |
| GABAb patients | – | Other: Clinical score of Granillo and al.Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : - Anti GABAb |
| GAD patients | – | Other: Clinical score of Granillo and al.Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : - Anti GAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : * Anti NMDAr * Anti LGI1 * Anti CASPR2 * Anti GABAb * Anti GAD
Key inclusion criteria (2 listed)
- Age > 18 years old
- Patient with a definite auto-immune encephalitis (Graus and al. 2016)
Key exclusion criteria (3 listed)
- Uncomplete data in acute phase
- Patient with several antibodies
- Opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical score of Granillo and al.Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF. | Other | CASPR2 patients, GABAb patients, GAD patients, LGI1 patients, NMDAr patients |
Primary outcome
Validation of a diagnostic score for encephalitis to assess the risk of autoimmune origin.
Time frame: At baseline
Comorbidities assessed by the Charlson score
Symptoms in the acute phase
Time frame: At baseline
Mode of onset of disease
Time frame: At baseline
Results of lumbar puncture
Time frame: At baseline
Results of antineuronal antibodies in CSF
Time frame: At baseline
Results of antineuronal antibodies in serum
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis and Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a diagnostic score for encephalitis to assess the risk of autoimmune origin. (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.